FDA 510(k) Application Details - K004017

Device Classification Name	Electrocardiograph, Ambulatory, With Analysis Algorithm   More FDA Info for this Device
510(K) Number	K004017
Device Name	Electrocardiograph, Ambulatory, With Analysis Algorithm
Applicant	MORTARA INSTRUMENT, INC. 7865 NORTH 86TH ST. MILWAUKEE, WI 53224 US Other 510(k) Applications for this Company
Contact	HARLAN L VAN MATRE Other 510(k) Applications for this Contact
Regulation Number	870.2800   More FDA Info for this Regulation Number
Classification Product Code	MLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2000
Decision Date	06/11/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review